Presentation at the 20th NMFP meeting held on 4-5 June 2019 at ECDC in Stockholm, Sweden.

1. BIOSAFETY AND BIOSECURITY
REGULATORY ENVIRONMENT AND
PRACTICES AT SCIENSANO
BELGIUM
Prof. Dr. Steven Van Gucht
Viral Diseases
Sciensano – Brussels
steven.vangucht@Sciensano.be
20th Meeting of the NMFP, 4-5th June 2019, Stockholm

2. What is Sciensano?
• National research institute for public and animal health
• April 2018 merger: →
• Staff: 700, Sites: 6

3. Scientific departments
Sciensano
Epidemiology
and public
health
Infectious
diseases in
humans
3 BSL3:
Avian influenza
Rabies virus
TBEV
Mycobacterium
tuberculosis ….
Infectious
diseases in
animals
3 BSL3(+):
Footh and mouth disease
Lumpy skin, capripox
Bluetongue
Schmallenberg
Avian influenza
West Nile virus……
Chemical and
physical health
risks
Expertise and
service
provision
SBB
(Biosafety and
biotechnology
service)
Belgian
Biosafety
server
Biosafety
committee

4. Regulatory framework
European:
Directive 2009/41/EC of the 6th of May 2009 on the contained use of GMO
Region (competent authority):
Regional decrees (since 1993): Flanders, Brussels, Wallonia
Scope: GMOs and pathogens (human, animal & plants)
Part of Environmental permit

5. Regulatory framework
Belgian (federal level): coordinates and
harmonizes implementation of EU Directives
↓
Sciensano:
Service of Biosafety and Biotechnology (SBB)
= Centre of expertise
- Belgian Biosafety Council
- Belgian Biosafety Server:
https://www.biosafety.be
Advisory role for regional authorities on
regulations, risk assessments, audits

6. Authorisation procedure Brussels Region
Biosafety dossier:
- technical (confidential) and public dossier
- Sent to competent authority and advisory body Sciensano (SBB)

7. Authorisation procedure Brussels Region
Bruxelles Environnement (IBGE BIM):
Central inventory since 1993
Authorization (environmental permit)
Inspections (with support from Sciensano SBB)
User:
Internal audits/ auto control: Biosafety officer
Incident/accident reporting
Yearly Reporting

8. Sciensano: roles and responsibilities
General Director: approves all new or changed activities
Biosafety Officer: advices personnel and director, contact point
Head of service: specific lab procedures

9. Sciensano: roles and responsibilities
Biosafety Bureau
• Presided by Biosafety Officer
• Delegate from every building (4), Facility Services, Quality Office
• Prevention Officer (worker’s safety, overlap)
• Delegate Occupational health service (external)
Local Biosafety Council
• Bureau + delegate from every lab/service
• Meets every month
• transfer of information - consultation
• report Incidents/accidents

10. Sciensano: risk assesment
List of pathogens and risks: https://www.biosafety.be
Risk class pathogen:
• 1 (e.g. bacteriophage)
• 2 (e.g. adenovirus)
• 3 (e.g. rabies virus)
• 4 (e.g.Ebola)
Risk class of activity: PCR versus virus culture, aerosol, volume and
concentration, sharps,…
Risk level pathogen + activity + > Appropriate containment level and
protective measures

11. Sciensano infrastructure
Requirements: regional authority > based on Belgian biosafety server
Biosafety level labs: 2, 2+, 3, 3+
ASL 2 and 3 (also large animals)
No BSL4 in Belgium
Diagnosis class 4 pathogens in BSL3 lab: e.g. Ebola virus inactivation and RNA
extraction for PCR, no culture

12. Laboratory equipment
Biosafety cabinets class 2, 3
Individually ventilated cages lab animals
Yearly maintenance, validation, certification by external contractor (cfr ISO17025, 15189)

13. Personal protective equipment
General budget versus project budget !
Gloves
Lab coats (tight cuffs)
FFP2/3 respiratory masks with fitting tests

14. Personnel competence and training
New personnel:
General training on biosafety
Lab-specific training by head of lab (no proficiency test)
Recorded in personal training program (cfr ISO17025, ISO15189)
Badge entrance BSL2+ or BSL3 labs: only after vaccination and training
Intranet
Biosafety Manual
Environmental permit
Contact persons
Reporting tool

15. Occupational health program: worker’s
safety
Legal obligation: medical clearance staff
External (IDEWE)
Risk analysis from head of lab
Preventive and post exposure prophylaxis
1-2/y medical check-up
Update vaccinations and serology if needed:
e.g. monitoring rabies antibodies every 6 months, <3 IU/ml = booster
Site visits

16. Sample receipt
International legislations: UN, ADR, IATA, Directive 2008/68/EC
Belgian Royal Decree 27/4/2007 (cat B)
Shipper is responsible
• Category A: UN 2814: High risk pathogen (life-threatening):
rigid triple packaging, trained staff, specialized transporter (World Courier)
• Category B: UN3373 regulation: Human samples with biological agent: triple
packaging, labelling, documentation
• Exempt human or animal samples (improbable risk): basic triple packaging
Centralized Dispatching Centre: sample tracking tool in Lab Information System
(LIMS)

17. Shipment of samples from peripheral lab to
reference lab: weak link

18. Inter/intra site transport

19. Decontamination and waste management
SOP: Elimination (PRO/5.1/04)
Bio-hazard containers:
collected by facility services > central storage >
specialized transporter (extern) > incineration (extern)
BSL3:
Autoclave: chemical (tape) and biological (spore)
indicators
Kill tanks for water waste, animal waste and carcasses
Disinfection spray for surfaces or fomites

20. Incident/emergency response plan
Procedures intranet
Legal obligation to notify
Report to head of lab > prevention officer, medical officer (external), biosafety
officer > report to authorities if necessary
Risk analysis and action plan
Record keeping of accidents/incidents
Accidental spill: spill kit and H2O2 decontamination

21. Some examples of biosafety incidents
Usually: human errors, lab-acquired infections
www.biosafety.be: survey Laboratory-Acquired Infections Belgium 2007-2012
Rabies: needle stick and eye exposure
Shigella contamination Sangria
Mycobacterium tuberculosis in researcher:
• Mantoux test / 6 months > IGRA test
• Thorax scan: granuloma’s > biopsy > isolation lab strain > treatment

22. Biosecurity
No regulation
Restriction for polioviruses only (GAPIII implementation)
Restricted access building and BSL3: yes
No risk assessment or audits
Inventory pathogens: no centralized control or procedure
Personnel background screening: no
My opinion:
limited risk from outsiders
potential risk: malignant insiders (e.g. stock of botulin toxins)
gain of function studies

23. Personnal experience
Risk perception: individual and lab culture
Risk of short term contracts and staff
turnover
My mantra:
No needles, rush or fear
Use disposables
Understand what you do

24. Thanks for your attention !